Click here for full Prescribing Information, including Instructions for Use, for SPIRIVA® RESPIMAT® (tiotropium bromide) Inhalation Spray.
IMPORTANT SAFETY INFORMATION
SPIRIVA® RESPIMAT® (tiotropium bromide) Inhalation Spray is contraindicated in patients with a hypersensitivity to tiotropium, ipratropium, or any component of this product. Immediate hypersensitivity reactions, including angioedema (including swelling of the lips, tongue, or throat), itching, or rash have been reported.
SPIRIVA RESPIMAT is intended as a once-daily maintenance treatment for COPD and should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. In the event of an attack, a rapid-acting beta2-agonist should be used.
Immediate hypersensitivity reactions, including urticaria, angioedema (including swelling of the lips, tongue, or throat), rash, bronchospasm, anaphylaxis, or itching may occur after administration of SPIRIVA RESPIMAT. If such a reaction occurs, discontinue SPIRIVA RESPIMAT at once and consider alternative treatments. Given the similar structural formula of atropine to tiotropium, patients with a history of hypersensitivity reactions to atropine or its derivatives should be closely monitored for similar hypersensitivity reactions to SPIRIVA RESPIMAT.
Inhaled medicines, including SPIRIVA RESPIMAT, may cause paradoxical bronchospasm. If this occurs, it should be treated with an inhaled short-acting beta2-agonist such, as albuterol. Treatment with SPIRIVA RESPIMAT should be stopped and other treatments considered.
SPIRIVA RESPIMAT should be used with caution in patients with narrow-angle glaucoma. Prescribers and patients should be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema). Instruct patients to consult a physician immediately should any of these signs or symptoms develop.
Since dizziness and blurred vision may occur with the use of SPIRIVA RESPIMAT, caution patients about engaging in activities such as driving a vehicle, or operating appliances or machinery.
SPIRIVA RESPIMAT should be used with caution in patients with urinary retention. Prescribers and patients should be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, painful urination), especially in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patients to consult a physician immediately should any of these signs or symptoms develop.
Patients with moderate to severe renal impairment (creatinine clearance of <60 mL/min) treated with SPIRIVA RESPIMAT should be monitored closely for anticholinergic side effects.
The most common adverse reactions >3% incidence and higher than placebo with SPIRIVA RESPIMAT (placebo) in COPD trials were pharyngitis 11.5% (10.1%), cough 5.8% (5.5%), dry mouth 4.1% (1.6%), and sinusitis 3.1% (2.7%).
SPIRIVA RESPIMAT may interact additively with concomitantly used anticholinergic medications. Avoid administration of SPIRIVA RESPIMAT with other anticholinergic-containing drugs.
Inform patients not to spray SPIRIVA RESPIMAT into the eyes as this may cause blurring of vision and pupil dilation.
SPIRIVA RESPIMAT, 2.5 mcg, is indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, and for reducing COPD exacerbations. SPIRIVA RESPIMAT is not indicated for relief of acute bronchospasm.
CL-SVR-0034 Spiriva Respimat ISI